Ampion is a novel biologic drug containing a blood-derived cyclized peptide and small molecules that target multiple pathways in the innate immune response characteristic of inflammatory disease. These ingredients work together to achieve an anti-inflammatory effect to treat a variety of inflammatory conditions, including osteoarthritis, respiratory illness, and other inflammatory diseases.
Mechanism of Action
Inflammation plays an important role in normal physiology. The immune system works to clear out damaged tissue and infectious agents during the inflammatory response, which is followed by tissue repair and healing during the anti-inflammatory response. Inflammatory conditions trap the normal immune response in a cycle of disease which leads to an overabundance of inflammatory mediators (cytokines) that creates a loop of continued inflammation, which trigger disease progression and pain in a wide range of debilitating and sometimes life-threatening illness. Ampion uses the power of the immune response to interrupt this damaging cycle and address the underlying causes of inflammation.
In vitro studies show that Ampion regulates the immune response by suppressing the production of proteins responsible for inflammation (inflammatory cytokines) while activating anti-inflammatory proteins (anti-inflammatory cytokines) responsible for signaling tissue growth and healing. This mechanism of action interrupts the cycle of inflammation and shifts the immune response back towards tissue repair and healing. The overall treatment effect provides anti-inflammatory relief to improve clinical outcomes for patients.
Ampion as a Platform Drug
Ampion achieves its biological effect by targeting the over production of cytokines, which is common in multiple inflammatory diseases like osteoarthritis, respiratory disease, and other inflammatory conditions. Ampion has been shown to uniquely reduce inflammation along multiple pathways, unlike other anti-inflammatory therapies that target only one mechanism.
Ampion has been developed for use, and has been cleared by the FDA for investigation, by multiple routes of administration.
- Injection places Ampion right where it is needed to locally treat inflammation. The osteoarthritis trials are evaluating the safety and efficacy of injection into the joint.
- Inhalation provides direct application of Ampion to locally treat inflammation in the lungs. The COVID-19 clinical trials are evaluating the safety and efficacy of Ampion inhalation in the lungs of COVID-19 patients with respiratory illness.
- Intravenous (IV) provides systemic application of Ampion to broadly treat inflammation throughout the body. The COVID-19 clinical trials are evaluating the safety and efficacy of Ampion IV treatment in COVID-19 patients with respiratory illness.
Ampion is considered a platform drug with many uses which are potentially useful for several inflammatory diseases throughout the body.
The starting material of Ampion in medical use for over 70 years, and it offers a strong safety profile. More than 2,000 patients have been treated with Ampion, and it has been found safe and well-tolerated in all clinical trials across multiple indications.
Intellectual Property Protection
Ampion is backed by a robust patent portfolio with intellectual property protection and eligible for 12-year FDA market exclusivity upon approval as a novel biologic under the Biologics Price Competition and Innovation Act (BPCIA).
Ampion is different than other anti-inflammatory medicines
Steroids and non-steroidal drugs like ibuprofen work by suppressing inflammation throughout the entire body, interfering with the body’s natural immune response and causing serious side
effects. Ampion works differently.